Title: ????????(Q-IWG) ???????
1????????(Q-IWG) ???????
2????
- ???????????????????,ICH Q-IWG????????????????????
???,?????????????ICH Q-IWG????????????????
3ICH Q8,Q9 Q10 ?????
- ???????????
- ????
- ????????
- ????????
- ?????????????????????????,??????????????
- ????????????
- QbD,?????????,QbD???????????,2?????????????????
- Quality by design?????
- ICH Q10????1
4?? ?????????
1. GMP???? ?? ????
2. ???????????????????????,????????????????(?ICH Q9?ICH Q10)? ?????? ?????????????????????????????
3. ???????????????????????,??????????????(? ICH Q8?ICH Q9)? ?????? ??????????????????? ??????????????????????????? ????????????????????
4. ???????????????????,??????????????????????????????(?ICH Q8,ICH Q9?ICH Q10)? ?????? ???????????????????????????? ??????????????????? ?????????????????????????,???????????????????????????? ?????????????????????????? ????????????????????
ICH Q10, Annex I
5?????????? ?????
- ???????
- ??????????
- ??????????
- QA????
- ??????/???
- ????????(Q-IWG)???????
6ICH Q-IWG?????
- QA 45????????????,??????????
- ICH???????(GCG)?ICH 3?????????
- ????????????PIC/S,PDA(PCMO),ISPE(PQLI),
- ????????????,???ICH?????????????????/?????
???????????? - ??????????
7Q-IWG ????? QA
- ?????(QA)?,ICH Q8,Q9???Q10????????3??????????????
?????? - ?????? 2008?10? ???QA ICH???????? 2009?4?
- ?? 2009?6? ??QA ICH???????? 2009?6?
- ?????? 2009?10? ??QA ICH???????? 2009?10?
- ???/?????D.C./????????????
- ???QA????????????
8Q-IWG QA???
- ?? ???
- ?????????? 3
- Quality by Design (QbD)?????? 1 3
- - ???????? 8 3
- - ???????????? 11 8
- - ???? 5
- ????????? 8 1
- GMP???? 3
- ???? 5
- ????????????? 1
- ?? 45 15
9Q-IWG ???????????
- ????????????????????????????????,?????????????????
????? - ?????????,????????????????????????
- ICH Q8,Q9,Q10????,?????????????????????,??????????
???????????
10??ICH Q-IWG??????/?????????
- ??3????????,ICH Q-IWG????????,???????
- ????????????????????????????????
- ??,??,???????
- ICH 3?????????,??????????????????????
- ?????,?????????????
- ??????????????Q-IWG QA ????????
- ???????????ICH????????,????(???????)??????????????
???????????? - ??????? ?????????????????????,???????????????????
? - ?????????
11Quality by Design(QbD)????????????
????
?????? ??????
QTPP????????????????
??????????(??,GMP,??, ...)
??????(CQA)
??????????(CQA)???? ?????????(CPP)???
??/???????
????????? (CPP)
???????????????(DOE??)????CQA?????????????
?????(DOE)
?????????????????CQA?????,????????????????
?????????
????????QRM?????
??
??/???????
????????,????????????
??????
????
?????? PQS
????
????
PQS GMP
?????????
PQS?????????(QP, ...)????????
?????
?????
????????????????????
12Q-IWG ????? ?????????
- ????Q-IWG???????????????
- ??????? ?????????/?????????
- ?????????????
- ????????
- ????
- ?????????
- ???????????
- Q-IWG????????????Q-IWG???????????
13THANK YOU
14??
???????????,ICH Quality Implementation Working
Group (Q-IWG)?????????????????
- Urs Kopp
- Akira Kusai
- Yoshihiro Matsuda
- Motoaki Mitsuki
- Elaine Morefield
- Jacques Morénas
- Masatoshi Morisue
- Markus-Peter Müller
- Tamiji Nakanishi
- Moheb Nasr
- Kazuhiro Okochi
- Anthony Ridgway
- Rachael Roehrig
- Stephan Rönninger
- Swroop Sahota
- Hideki Sasaki
- Tetsuhito Takarada
- Shigeki Tamura
- Krishnan Tirunellai
- Mats Welin
- Jean M. Wyvratt
- A J van Zyl
- Jean-Louis Robert (rapporteur)
- Diana Amador-Toro
- Robert G. Baum
- Nicholas Cappuccino
- David Cockburn
- Georges France
- Richard L. Friedman
- Nigel Hamilton
- Hirotada Nagai
- Yukio Hiyama
- Fusashi Ishikawa
- Takao Kiyohara